Moncton, New Brunswick and Cambridge, Massachusetts--(Newsfile Corp. - December 16, 2025) - Breathe BioMedical, a company developing a breath analytics platform for early disease detection, today announced the launch of the third site in its large multi-center observational collection protocol study to advance the development of its breath test for the early detection of breast cancer in females with dense breasts, as an adjunct to mammography.

Breath sample collection has started at George Washington University Breast Center and Duke University in Durham, North Carolina.

Dr. James Jakub, Surgical Oncologist and Professor of Surgery and Dr. Pooja Advani, Breast Medical Oncologist and Researcher, both of Mayo Clinic in Florida, will serve as Co-Principal Investigators of the study and site leads in Jacksonville.

Researchers will compare the breath profiles of females with dense breasts with breast cancer and those without breast cancer, with the goal of identifying disease-specific patterns that can be leveraged to facilitate breast cancer detection.

This new study will compare the breath profiles of females from a variety of patient populations across a range of demographics and geographic areas to further develop Breathe BioMedical's technology and enhance its machine learning algorithm's capability to differentiate between the breath profiles of females with breast cancer and those without breast cancer. The study will assess sensitivity, specificity, false negative rate and false positive rate.

"Mammography has well-recognized limitations, particularly for individuals with dense breast tissue, underscoring the urgent need for complementary, non-invasive, and scalable diagnostic solutions," said Bill Dawes, CEO of Breathe BioMedical. "By expanding our clinical study with new partners, we are accelerating the collection of robust breath-based data to advance the development of our machine learning-driven detection model. We're excited to welcome this new clinical site into our growing network of collaborators and remain committed to working with leading institutions to drive innovation in early breast cancer detection."

Approximately 50% of the 70 million women in the U.S. that are eligible for breast cancer screening have dense breast tissue, making them 4 to 5 times more likely to develop breast cancer than women without dense breast tissue. Although mammography is the current gold standard for breast cancer screening, the interpretation of a mammogram can be especially challenging with dense breast tissue, because both tumors and dense breast tissue appear white on a mammogram. Evidence suggests that mammography alone fails to detect breast cancer in 30%-50% of women with dense breast tissue.

About Breathe BioMedical
Breathe BioMedical is developing an innovative breath analytics platform to enable the early detection of disease. Our proprietary breath analytics technology is designed to collect, process and analyze breath samples to identify biomarker patterns associated with specific diseases. Breathe BioMedical is focused first on developing a breath test for breast cancer detection for women with dense breast tissue, as an adjunct to mammography, with the goal of increasing the number of breast cancer cases identified at the earliest stages. Breathe BioMedical is headquartered in Moncton, New Brunswick, with a US subsidiary in Cambridge, Massachusetts. One day, detecting disease may be as easy as breathing.

For more information, please visit our website and follow us on LinkedIn.

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